Sr Manager/Assoc Director, External Manufacturing Operations (Drug Product)

Description

Job Title: Sr. Manager / Associate Director, External Manufacturing Operations (Drug Product)

Company: Immunome, Inc.

Location: Bothell, WA or Remote

Company Overview: 

Immunome is a biotechnology company dedicated to developing first-in-class and best-in-class targeted cancer therapies. Our portfolio pursues each target with a modality appropriate to its biology, including small molecules, ADCs, and RLTs. We believe that pursuing underexplored targets with appropriate drug modalities leads to transformative therapies. Our proprietary memory B cell hybridoma technology allows for the rapid screening and functional characterization of novel antibodies and targets.

Position Overview:

The Sr. Manager / Associate Director is responsible for meeting Immunome’s supply requirements by enabling and overseeing operations performed at Contract Development and Manufacturing Organizations (CDMOs). This role focuses on drug product manufacturing but will support additional operations as needed, for biologics and small molecule programs.  

Key Responsibilities:

• Serve as the Supplier Relationship Manager (SRM) for specified CDMOs and primary liaison between the CDMO and Immunome.
• Collaborate closely with Legal to support the development and negotiation of service agreements, supply contracts, and statements of work across development and commercial phases. 
• Lead one or more Virtual Management Teams (VMTs) comprising Quality, Product Supply, Technical Development, and other cross-functional stakeholders as necessary. Ensure Immunome’s project deliverables stay on-track. Align priorities and key communications with the CDMO.  
• Conduct well-organized and documented project team meetings with CDMOs. Ensure CDMO progress is tracking to plan (e.g., campaign preparation, manufacturing operations, release activities, logistics, etc.). Proactively address delays to avoid impact on supply or regulatory milestones.   
• Develop a thorough understanding of Immunome’s drug product manufacturing processes. Support technical reviews of master and executed batch records, specifications, investigations, and change requests, as required.
• Monitor CDMO performance through Key Performance Indicators (KPIs) and drive improvements aligned with Immunome’s expectations. Lead or participate in periodic Business Review Meetings. 
• Work closely with department management and Finance to provide timely progress updates. Ensure that unexpected cost variances are communicated quickly. 
• Maintain comprehensive knowledge of the CDMO’s systems, capabilities, capacities, requirements, and business practices. 
• Monitor spending against budget. Ensure CDMO invoicing is accurate and aligned with contractual terms. 

Other Responsibilities and Projects:

• Assist with technology transfers as needed, change implementation, and regulatory submission reviews. 
• Support Technical Operations sourcing efforts and the qualification of new CDMOs.  
• Support risk assessment development, and the implementation of manufacturing network strategies.
• This is an individual contributor role. Depending on the business need, and organizational considerations, this role may include staff supervisory responsibly as the product portfolio and manufacturing network expand.  

Requirements

Education and Experience:

• Bachelor’s or advanced degree in biotechnology, biology, chemistry, chemical engineering, or related field.
• Minimum of 10 years of industry experience, and direct responsibility overseeing third parties performing cGMP manufacturing.   

Knowledge and Skills:

• Strong organizational, communication, and collaboration skills.
• Strong technical background in biotechnology/pharmaceutical manufacturing or process development. 
• Hands-on expertise in drug product process development or cGMP drug product manufacturing. Experience with highly potent products is desired. 
• Prior success in overseeing external manufacturing operations is required, either as an SRM or Subject Matter Expert (SME). Experience with both clinical and commercial manufacturing is desired.
• Must be well-versed in Quality systems and experienced with deviation investigations, change controls, and corrective actions.
• Must possess strong negotiation skills and be versed in general contractual terms. 
• Must be comfortable with ambiguity and uncertainty; must adapt swiftly with focus on delivering to the business needs as priorities change. 

Position will require domestic and international travel (up to 25%) and occasional evening